An interventional study of No pubic hair and Pubic Hair in Healthy, sponsored by Margaret Mueller. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Margaret Mueller · Not applicable, Interventional, and Basic science
This research study seeks to find if there is a connection between the presence of pubic hair and the type of bacteria that live in the vagina and bladder.
Urinary tract infections (UTIs) are the most common bacterial infections. In 2007, in the United States alone, there were an estimated 10.5 million office visits for UTI symptoms (constituting 0.9% of all ambulatory visits) and 2-3 million emergency department visits. UTIs are significantly more common in women and are a leading cause of urogynecology referrals. In women, the vagina plays a key role in the pathogenesis of UTIs. The initial step in the pathogenesis of UTI is colonization of the vaginal opening and peri-urethra with uropathogens from the intestinal microbiota, followed by ascension of uropathogens via the urethra to the bladder and sometimes the kidneys to cause infection. Thus, understanding factors that affect the microbiota of the vagina is key to understanding the pathogenesis of UTI. Likewise, since Wolfe et al published the first evidence of a urinary microbiome in 2012, there has been growing interest in whether the content of this microbiome could correlate with symptoms of the lower urinary tract. The urinary microbiome has been shown to correlate with symptoms of urgency incontinence but to date, there is no data on whether the composition of the urinary microbiome is associated with any change in risk for UTIs. If the urinary microbiome could play a role in the acquisition of clinical infection, then the factors that affect the microbiome of the bladder would be important in preventing UTIs. One plausible and modifiable factor that may change the vaginal and urinary microbiome is the presence of pubic hair. Hair in other parts of the body (nose, ears, eyebrows) traps and stops the passage of pathogens into our mucous membranes. Additionally, the sebum produced by hair follicles is bacteriostatic. However, some form of pubic hair grooming is performed by the majority of pre-menopausal women (83%) and 62% of women between age 18-40 report having removed ALL of their pubic hair at one point in life. This is predominantly done by using non-electric razors (61%) but other women use lasers, waxing and depilatory creams. Fifty-nine percent of women who perform pubic hair removal report their primary reason is to improve hygiene. However, there is no data that this practice changes hygiene, with the exception of preventing pubic hair lice. On the contrary, pubic hair removal has been associated with skin injury leading to inoculation of bacteria and viruses. In a recent cross-sectional study of pubic hair and sexually transmitted infections, researchers found that frequent pubic hair grooming was correlated with a higher risk for sexually transmitted infections (STIs). This preliminary work raises the question of whether the presence of pubic hair affects the vaginal or urinary microbiome, thereby changing a woman's risk of infection in either organ. Furthermore, specific pelvic floor disorders (PFDs) including painful bladder syndrome and urgency urinary incontinence have been associated with specific microbiome profiles. Therefore, by falsely attempting to maintain pelvic health through grooming practices, women might inadvertently be exposing themselves to PFDs mediated by changes in their urinary or vaginal microbiomes. The aim of this study is to address this question through a pilot study of urinary and vaginal microbiomes in women with and without pubic hair AND in the same woman with and without pubic hair.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's enrollment of 43 is below the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →This is the only study on the registry with Margaret Mueller as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: Women will be excluded for any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant with natural hair crosses over to removed pubic hair
Behavioral: No pubic hair
Participant with no pubic hair crosses over to natural pubic hair
Behavioral: Pubic Hair
Natural pubic hair to fully removed pubic hair
Removed pubic hair to natural pubic hair
Comparison of Urinary and Vaginal Microbiomes
Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair
Time frame: up to 3 months
Questionnaire Comparison
To compare questionnaire results for standardized patient surveys in the same woman with and without pubic hair
Time frame: up to 3 months
Self-Reported Infections
Comparing self-reported vaginal infections and urinary tract infections between women who have natural pubic hair and women who fully remove their pubic hair
Time frame: up to 3 months
Subtracting Microbiome Results
To suggest whether the transurethral urinary microbiome can be determined by subtracting the vaginal microbiome from the voided urinary microbiome
Time frame: up to 3 months
Ran from Oct 2017 to primary completion in Jun 2019, 20 months.
Of 22 interventional studies with no phase under Vaginitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 20 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.